US20120165842A1 - Endoluminal fold creation - Google Patents

Abstract

Devices and methods are provided for forming one or more plications in the walls of a body cavity. In particular, endoscopic devices and methods are provided for forming and/or securing endoluminal tissue folds to reduce the volume of the gastric cavity. An end effector that includes a tissue receiving cavity can be delivered to a desired surgical site to allow a tissue fold to be formed within the tissue receiving cavity. A fastener can be used to secure the adjacent layers of tissue that form the tissue fold. The tissue folds can be effective to limit the stomach's capacity and create a feeling of satiety.

Description

FIELD OF THE INVENTION
• The present invention relates generally to devices and methods for performing surgical procedures, and more particularly to endoscopic devices and methods for forming an endoluminal fold to reduce the volume of the gastric cavity.
BACKGROUND OF THE INVENTION
• Obesity is a serious medical condition that affects more than 30% of the U.S. population and contributes significantly to morbidity and mortality. Complications associated with obesity include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, multiple orthopedic problems, pulmonary insufficiency, and markedly decreased life expectancy. Additionally, obesity often affects an individual's quality of life. Accordingly, the monetary, physical, and psychological costs associated with obesity can be substantial. In fact, it is estimated that costs related to obesity exceed more than 100 billion dollars annually.
• A variety of bariatric surgical procedures have been developed to treat obesity, the most common of which is the Roux-en-Y gastric bypass (RYGB). In a RYGB procedure, a small stomach pouch is separated from the remainder of the gastric cavity and attached to a resectioned portion of the small intestine. However, because this complex procedure requires a great deal of operative time, as well as extended and often painful post-operative recovery, the RYGB procedure is generally only utilized to treat people with morbid obesity.
• In view of the highly invasive nature of the RYGB procedure, other less invasive bariatric procedures have been developed such as the Fobi pouch, bilio-pancreatic diversion, gastroplasty (“stomach stapling”), and gastric banding. In addition, implantable devices are known which limit the passage of food through the stomach. Gastric banding procedures, for example, involve the placement of a small band around the stomach near the junction of the stomach and the esophagus to restrict the passage from one part of the digestive tract to another, thereby affecting a patient's feeling of satiety.
• While the above-described bariatric procedures are commonly used for the treatment of morbid obesity (i.e., greater than 100 pounds over one's ideal body weight), the risks of these procedures often outweigh the potential benefits for the growing segment of the population that is considered overweight. The additional weight carried around by these persons can still result in significant health complications but does not justify more invasive treatment options. However, because conservative treatment with diet and exercise alone may be ineffective for reducing excess body weight, treatment options should involve a less invasive, lower cost solution for weight loss.
• It is known to create cavity wall plications though endoscopic procedures. However plication depth has traditionally suffered in transesophageal procedures due to the size restrictions of the endoscopic lumen. Endoluminal approaches are restricted by the rigid length and diameter that can be reliably and safely passed transorally into the stomach. Furthermore, access and visibility within the gastric and peritoneal cavities is limited in a purely endoscopic procedure as the extent of the reduction increases.
• With the foregoing in mind, it is desirable to have a surgical weight loss procedure that is inexpensive, with few potential complications, and that provides patients with a weight loss benefit while buying time for the lifestyle changes necessary to maintain the weight loss. Further, it is desirable that the procedure be performed endoluminally in order to be less invasive to the patient, allowing for a quick recovery and less scaring. Additionally, it is desirable to have an apparatus for forming deep serosa to serosa tissue folds within the gastric lumen while limiting the potential risk to adjacent organs and tissue. Furthermore, it is desirable to have an apparatus for forming tissue plications in which the rigid length and diameter of the apparatus is minimized for transoral passage, yet can form tissue folds that are deeper than the initial rigid length of the apparatus. Yet further still, it is desirable to have apparatus for forming tissue plications within a gastric lumen which is of reduced complexity and which is combinable with a tissue anchoring device to facilitate secure tissue plications through a minimal number of transoral intubations.
SUMMARY OF THE INVENTION
• The present invention provides surgical devices and methods for forming one or more plications (i.e., tissue folds) in the wall of the gastric cavity. The plication(s) can be effective to reduce the volume of the gastric cavity, thereby limiting the stomach's capacity and creating a feeling of satiety. The plication(s) can also alter gastric motility to reduce the efficiency by which the stomach contributes to the digestion of food. The plication(s) can be comprised to create serosa-to-serosa apposition within at least a portion of the infolded region.
• In one embodiment, an endoscopic instrument is provided having an elongate, flexible shaft having proximal and distal ends, an end effector disposed at the distal end of the elongate shaft, a tissue manipulator, and a fastener for securing adjacent layers of tissue. The end effector includes a tissue receiving cavity that has a first length in a delivery configuration, and a second length in a treatment configuration that is greater than the first length. The tissue manipulator is associated with the end effector and is configured to engage tissue to enable the tissue to be positioned within the tissue receiving cavity in the treatment configuration to create a tissue fold. The fastener is configured to secure adjacent layers of tissue that form the tissue fold disposed within the tissue receiving cavity. The tissue fold can have a depth greater than the first, delivery length of the tissue receiving cavity.
• The end effector can include first and second jaws that define the tissue receiving cavity. In one embodiment, the jaws can be extendable such that the jaws can be moved between the delivery configuration to the treatment configuration. In one embodiment, the jaws can be disposed within a moveable sheath in the delivery configuration, and the sheath can be proximally retracted in the treatment configuration. The first length of the tissue receiving cavity can be substantially zero.
• The tissue manipulator is configured to engage tissue and can be axially extendable and retractable. In one embodiment, the tissue manipulator includes a distal tip that is configured to removably couple to tissue. The distal tip can be, for example, one or more of a corkscrew, vacuum port, and clamp. In one aspect, the endoscopic instrument can also include a stabilization element that is configured to constrain lateral movement of the tissue manipulator. For example, the stabilization element can be a sheath disposed around the tissue manipulator or a housing coupled to the tissue manipulator and slidably coupled to the end effector.
• In another aspect, an endoscopic instrument is provided having an elongate, flexible shaft having proximal and distal ends, an end effector having first and second arms disposed at the distal end of the shaft, a tissue manipulator, and a fastener configured to secure adjacent layers of tissue. The end effector can be moveable between a delivery configuration and a treatment configuration and the first and second arms can define a tissue receiving cavity in the treatment configuration. The tissue manipulator can be configured to engage tissue to enable the tissue to be positioned within the tissue receiving cavity in the treatment configuration to create a tissue fold. The fastener can be configured to secure adjacent layers of tissue that form the tissue fold disposed within the tissue receiving cavity. The tissue fold can have a depth greater than the maximum rigid length of the end effector in the delivery configuration. In one aspect, the end effector can have a maximum rigid length in the treatment configuration that is greater than the maximum rigid length in the delivery configuration.
• The arms of the end effector can have a variety of configurations. In one embodiment, at least one of the arms of the end effector can be a segmented arm formed of a plurality of connected link segments. The link segments can be flexibly coupled relative to one another in the delivery configuration to form a flexible segmented arm. In another aspect, the link segments can be rigidly coupled relative to one another in the treatment configuration to form a rigid segmented arm. In another aspect, the endoscopic instrument can include an actuator coupled to the segmented arm and configured to move the segmented arm between a flexible configuration and a rigid configuration.
• In other aspects, a method for forming an endoluminal fold of tissue within a body cavity is provided. The method can include inserting an instrument having a flexible shaft and an end effector into a body cavity through a natural opening in a body. The end effector can have first and second jaws that are effective to define a tissue receiving cavity having a first length in a delivery configuration. The end effector can be manipulated to cause the tissue receiving cavity to have a second length greater than the first length. The method can also include manipulating tissue to create a tissue fold that is positioned within the tissue receiving cavity and fastening the tissue fold to secure adjacent layers of tissue that form the tissue fold. The length of the tissue fold can be substantially the same as the second length and greater than the first length.
• The end effector can be manipulated to cause the tissue receiving cavity to have a second length greater than the first length in various ways. In one aspect, the end effector can be manipulated by manipulating the jaws. In one embodiment, the jaws can be distally extended. For example, extension members coupled to the jaws can be distally extended. In another aspect, the end effector can be manipulated by retracting a sheath disposed around the jaws in the delivery configuration, such that the jaws extend distally from the sheath.
• In one aspect, tissue can be manipulated to create a tissue fold that is positioned within the tissue receiving cavity. In one embodiment, manipulating the tissue comprises removably engaging tissue with a tissue manipulator associated with the end effector. The tissue manipulator can be retracted to pull the tissue within the tissue receiving cavity. Further, the jaws of the end effector can be manipulated before or after the tissue manipulator is retracted.
• In one aspect, the depth of the tissue fold can be substantially the same as the second length of the tissue receiving cavity and greater than the first length of the tissue receiving cavity in the delivery configuration. In one aspect, the depth of the tissue fold can be greater than the maximum length of the end effector in the delivery configuration.
• In one aspect, the tissue fold can be fastened by securing adjacent layers of tissue that form the tissue fold. For example, a tissue fastener can be inserted through the adjacent layers of tissue that form the tissue fold. In another aspect, energy can be applied to the tissue fold to bond the adjacent layers.
• In other aspects, a method for forming an endoluminal fold of tissue within a body cavity is provided. The method can include inserting an instrument having a flexible shaft and an end effector into a body cavity through a natural opening in a body. The end effector can include a tissue receiving cavity and at least one electrode configured to deliver energy to tissue disposed in the tissue receiving cavity. The end effector can be positioned adjacent tissue to be treated and the tissue can be manipulated to create a tissue fold that is disposed within the tissue receiving cavity. The method can also include delivering energy to the tissue fold disposed within the tissue receiving cavity through the at least one electrode such that adjacent layers of the tissue that form the tissue fold are secured. In one embodiment, the end effector can be moveable between a delivery configuration and a treatment configuration, wherein the tissue fold has a depth greater than a length of the tissue receiving cavity in the delivery configuration.
• Various types of energy can be employed to secure the layers of tissue. For example, RF energy or ultrasonic energy can be applied to the tissue fold to bond the tissue layers.
• In one aspect, delivering energy to the tissue fold can include contacting opposed serosal layers of the tissue fold and applying energy thereto to bond the opposed layers. The at least one electrode for delivering the energy can have a variety of configurations. In one embodiment, the at least one electrode can be a needle that is moveably disposed within one of the jaws of the end effector. The needle can be activated after the needle is inserted through at least a portion of the tissue that forms the tissue fold. The needle can be inserted substantially along a central axis of the tissue fold, or substantially transverse to the tissue fold. In one embodiment, the needle can be inserted through both of the adjacent layers of the tissue that form the tissue fold.
• In other aspects, an endoscopic instrument is provided that can include an elongate, flexible shaft having proximal and distal ends, an end effector having a tissue receiving cavity and at least one electrode associated therewith effective to deliver energy to tissue disposed in the tissue receiving cavity, and a tissue manipulator configured to engage tissue to enable tissue to be disposed within the tissue receiving cavity to create a tissue fold. The endoscopic instrument can also include an actuator effective to cause energy to be delivered through the at least one electrode to the tissue fold such that adjacent layers of the tissue that form the tissue fold can be secured.
• The end effector can be disposed at the distal end of the shaft and can have various configurations. For example, the end effector can be moveable from a delivery configuration to a treatment configuration, wherein the tissue fold has a depth greater than a length of the tissue receiving cavity in the delivery configuration. In one aspect, the end effector can include first and second jaws. The electrode can be movable from a first position substantially within one of the jaws, to a second position at least partially within the tissue receiving cavity. The electrode is configured to penetrate tissue within the tissue receiving cavity as the electrode moves from the first configuration to the second configuration. In one aspect, the electrode can be configured to penetrate tissue substantially transverse to the tissue fold, or alternatively, the electrode can be configured to penetrate tissue substantially along a central axis of the tissue fold. In one aspect, the electrode can be configured to penetrate both of the adjacent layers of the tissue that form the tissue fold.
• The electrodes can also be configured to deliver various types of energy to secure the layers of tissue. For example, the electrodes can be configured to deliver radiofrequency (RF) or ultrasonic energy to bond the tissue layers.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 illustrates one exemplary embodiment of a surgical device effective to create an endoluminal tissue fold, the device being disposed through an endoscope inserted into the upper gastrointestinal tract of a patient;
• FIG. 2 is a perspective view of the distal portion of the surgical device ofFIG. 1 disposed within the gastric cavity;
• FIG. 3 is a perspective view of the distal end of the fastener ofFIG. 2;
• FIG. 4A is a partial cross-sectional view of the end effector of the surgical device ofFIG. 1;
• FIG. 4B is a partial cross-sectional view of the end effector of the surgical device ofFIG. 1 with a tissue fold disposed therein;
• FIG. 5 is a perspective view of the end effector of the surgical device ofFIG. 1, showing a tissue anchor being deployed into a tissue fold disposed within the end effector;
• FIG. 6 is a sectional, perspective view of a gastric cavity showing a tissue fold formed in the anterior wall of the cavity;
• FIG. 7A is a side view of one embodiment of an end effector for use with the surgical device ofFIG. 1, the end effector having opposed arms and a tissue manipulator effective to engage tissue;
• FIG. 7B is a side view of the end effector ofFIG. 7A showing the tissue manipulator being retracted to initiate a tissue fold;
• FIG. 7C is a side view of the end effector ofFIG. 7A showing the tissue manipulator fully retracted such that a tissue fold is disposed between the opposed arms;
• FIG. 8A is a side view of another embodiment of an end effector for use with the surgical device ofFIG. 1, the end effector having opposed arms and a tissue manipulator effective to engage tissue;
• FIG. 8B is a side view of the end effector ofFIG. 8A showing the tissue manipulator fully retracted such that a tissue fold is disposed between the opposed arms;
• FIG. 8C is a side view of the end effector ofFIG. 8A showing the opposed arms of the tissue manipulator being extended to lengthen the tissue fold;
• FIG. 9A is a side view of another embodiment of an end effector for use with the surgical device ofFIG. 1, the end effector having opposed arms and a tissue manipulator effective to engage tissue;
• FIG. 9B is a side view of the end effector ofFIG. 9A showing the opposed arms being extended to initiate a tissue fold;
• FIG. 9C is a side view of the end effector ofFIG. 9A showing the opposed arms fully extended with a tissue fold disposed therebetween;
• FIG. 9D is a side view of the end effector ofFIG. 9A showing the opposed arms fully extended and the tissue manipulator fully retracted;
• FIG. 10 is a side view of another embodiment of an end effector for use with the surgical device ofFIG. 1;
• FIG. 11A is a side view of another embodiment of an end effector for use with the surgical device ofFIG. 1, the end effector having a sheath disposed therearound;
• FIG. 11B is a side view of the end effector ofFIG. 11A showing the sheath and tissue manipulator being retracted to initiate a tissue fold;
• FIG. 11C is a side view of the end effector ofFIG. 11A showing the sheath and tissue manipulator fully retracted such that a tissue fold is disposed between the opposed arms;
• FIG. 12A is a side view of another embodiment of an end effector for use with the surgical device ofFIG. 1, the end effector having a tissue manipulator effective to engage tissue;
• FIG. 12B is a side view of the end effector ofFIG. 12A showing one of the opposed arms in a treatment configuration such that the tissue fold is disposed between the opposed arms;
• FIG. 13A is a side view of another embodiment of an end effector for use with the surgical device ofFIG. 1;
• FIG. 13B is a perspective view of the end effector ofFIG. 13A;
• FIG. 14A is a perspective view of another embodiment of an end effector for use with the surgical device ofFIG. 1, the end effector having opposed arms in a low-profile configuration;
• FIG. 14B is a perspective view of the end effector ofFIG. 14A showing the opposed arms in an open, delivery configuration;
• FIG. 14C is a perspective view of the end effector ofFIG. 14A showing the opposed arms in a closed configuration;
• FIG. 14D is a partial cross-sectional side view of the end effector ofFIG. 14A showing the opposed arms in a closed configuration with a tissue fold disposed therebetween;
• FIG. 15 is a perspective view of another embodiment of an end effector for use with the surgical device ofFIG. 1, the end effector having a tissue manipulator effective to engage tissue;
• FIG. 16A is a cross-sectional view of the end effector ofFIG. 15 showing the tissue manipulator in a retracted position such that a tissue fold is disposed within the end effector;
• FIG. 16B is cross-sectional view of the end effector ofFIG. 15 showing a fastener being applied to the tissue fold;
• FIG. 16C is a cross-sectional view of the end effector ofFIG. 15 showing a fastener disposed around the tissue fold to secure the tissue fold;
• FIG. 17 is a side view of another embodiment of an end effector for use with the surgical device ofFIG. 1, the end effector having an electrode for delivering energy to a tissue fold disposed within the end effector;
• FIG. 18 is a side view of another embodiment of an end effector for use with the surgical device ofFIG. 1, the end effector having an electrode for delivering energy to a tissue fold disposed within the end effector;
• FIG. 19A is a perspective view of another embodiment of an end effector for use with the surgical device ofFIG. 1, the end effector having an electrode for delivering energy to a tissue fold disposed therein; and
• FIG. 19B is a partial cross-sectional side view of the end effector ofFIG. 19A with a tissue fold disposed within the tissue receiving cavity of the end effector.
DETAILED DESCRIPTION OF THE INVENTION
• Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment can be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
• Various exemplary methods and devices are provided for creating a tissue fold to reduce the volume of the gastric cavity. The devices can be inserted transorally into the gastric cavity to involute and secure one or more sections of the cavity wall to form a serosa-to-serosa tissue fold. The devices described herein for forming an endoluminal tissue fold can have a number of different configurations but are generally designed to minimize the rigid length and diameter of the device to allow for transoral passage while maximizing the obtainable fold depth. Although in certain exemplary embodiments, the surgical device generally includes or is associated with a flexible shaft for insertion into the gastric cavity of a patient and an end effector for creating a serosa-to-serosa tissue fold, and a fastener for securing adjacent layers of tissue that form the serosa-to-serosa tissue fold, a person skilled in the art will appreciate that the concepts described herein can be applied to other surgical, therapeutic, or diagnostic devices in which it is desirable to form and secure tissue plications.
• FIGS. 1-6 depict one exemplary embodiment of a surgical instrument for creating an endoluminal fold. As illustrated inFIG. 1, thesurgical instrument10 can be disposed within a natural body lumen to deliver theend effector20 to a surgical site within the gastric cavity. As shown, thesurgical instrument10 can be disposed within an overtube orendoscope2 for transesophageal access to a surgical site within thegastric cavity4 of a patient. Although the illustratedsurgical instrument10 is shown delivered to the surgical site through the mouth and esophagus, it will be appreciated by a person skilled in the art that thesurgical instrument10 can be delivered to an internal surgical site through any opening within a patient's body, whether a natural orifice (e.g., orally, anally, or vaginally) or a surgical opening (e.g., through a trocar in a percutaneous incision, percutaneously, laparascopically, through a hybrid laparascopic-endoscopic approach, or an open surgical procedure). Thesurgical instrument10 can also be delivered to a surgical site through the orifice or opening directly, without the use of an auxiliary endoscope, trocar, or other access port.
• As shown in more detail inFIG. 2, thesurgical instrument10 generally includes anelongate shaft12, anend effector20 disposed at the distal end of theelongate shaft12, and atissue manipulator40. Theend effector20 can define atissue receiving cavity26 in which a tissue fold can be formed. Thetissue manipulator40 can be configured to engage tissue to enable tissue to be positioned within thetissue receiving cavity26 to form the tissue fold. Thesurgical instrument10 can also include afastener60 associated therewith that is configured to secure adjacent layers of the tissue fold. As will be described in detail below, thefastener60 can be integral with or coupled to thesurgical instrument10 itself or can be delivered and/or manipulated independent of theend effector20.
• Again referring toFIG. 1, thesurgical instrument10 can optionally include ahandle assembly14 operatively coupled to theend effector20 and disposed external to the patient's body for facilitating control of thesurgical device10 and/or operation of theend effector20. A person skilled in the skill in the art will appreciate that any of the various handle assemblies known in the art can be used including, for example, scissor-grip, pistol-grip, spool style handles, syringe style handles, and various other handle configurations modified in accord with the teachings herein. Alternatively, the user can operate thesurgical device10 manually, i.e., without the use of a handle assembly. By way of non-limiting example, the user can operate theend effector20 by actuating controls (e.g., control wires, cables, etc.) that are configured to manipulate theend effector20 directly without the need for a handle assembly.
• Theelongate shaft12 is generally configured to extend from external to the patient's body to the surgical site and can have a variety of configurations. Generally, as shown inFIG. 1, theend effector20 can be disposed on the distal end of theelongate shaft12 and the proximal end of theelongate shaft12 can extend outside the patient's body. Theelongate shaft12 can also define a lumen through which a variety of actuating mechanisms (e.g., cables, control wires, etc.) can extend for operating theend effector20. A person skilled in the art will appreciate that any of the various shafts for endoscopic, laparoscopic, percutaneous, and other minimally invasive surgical devices known in the art can be modified in accord with the teachings herein for use with the present invention.
• In an exemplary embodiment, at least a portion of theelongate shaft12 is flexible or semi-flexible to allow theshaft12 to be inserted into a patient translumenally, e.g., through a natural orifice, an endoscope, or a surgical incision. While various materials and techniques can be used to form the shaft, theelongate shaft12 can be formed, for example, from a friction reducing flexible outer sheath having a flat coil wire extending therethrough. The flexibility of theshaft12 can also vary along its length and theshaft12 can be formed from one or more components that are mated together.
• As will be described in detail below, the end effector for use with the surgical device of the present invention can have a variety of configurations, but generally includes a tissue receiving cavity in which a tissue fold can be formed. As shown inFIG. 2, theend effector20 can include a pair ofjaws24 that project distally from the distal end of thebody22. Thejaws24 are spaced apart to define atissue receiving cavity26 therebetween.
• Thejaws24 can have a variety of configurations. For example, as depicted inFIG. 2, the distal ends of thejaws24 can be outwardly flared so as to increase the size of the distal opening of thetissue receiving area26. Such a configuration can allow for tissue to be more easily drawn into thetissue receiving area26. Alternatively or in addition, the inner surfaces of thejaws24 facing thetissue receiving cavity26 can have a concave shape to further increase the volume of tissue that can be disposed between thejaws24. Though thejaws24 are shown as being substantially parallel to one another, the distance between thejaws24 can also vary along their length. For example, the distance between thejaws24 can decrease proximally so as to press together the adjacent layers of tissue that form the tissue fold as the tissue is drawn down between thejaws24.
• As will be appreciated by a person skilled in the art, thejaws24 can be integral with or fixedly or removably coupled to thebody22 of theend effector20. Further, thoughFIG. 2 depicts thejaws24 coupled to thebody22 such that thejaws24 maintain a fixed position relative to each other and thebody22, the first and second jaws can alternatively be moveably coupled to theend effector20 such that the jaws can move relative to theend effector20 and/or one another, as will be described below. As shown inFIG. 2, the fixed distance between thejaws24 can help separate the cavity wall from surrounding organs as thecavity wall6 is drawn into thetissue receiving cavity26. By excluding adjacent organs, thejaws24 can reduce the risk of adjacent organs being damaged or fastened as part of thetissue fold8.
• As will be appreciated by a person skilled in the art, the jaws can also have a variety of shapes, sizes, and lengths depending on the procedure to be performed. The length of thejaws24 and the distance between thejaws24 can vary in order to maximize the depth of the tissue fold. In one aspect, thejaws24 define atissue receiving cavity26 having a length equal to or greater than the desired depth of the tissue fold, such that a tissue fold can be formed and secured through a single tissue acquisition, eliminating the need for multiple tissue bites in order to achieve the desired tissue fold depth.
• Controls can also be provided for positioning and/or articulating theend effector20 and can have a variety of configurations. For example, as shown inFIG. 2, the controls can be in the form of a plurality ofcontrol rods27 connected to thebody22 of theend effector20. By way of non-limiting example, a pair of control rods can be attached on opposite sides ofbody22, while a third rod can be connected to a centralized point at the base of theend effector20. Therods27 can articulate theend effector20 in a range of about −90° to 90° from a linear configuration in which thejaws24 extend parallel to the longitudinal axis of theelongate shaft12. Therods27 can extend proximally through theovertube2 to an externally controllable actuating assembly to control articulation of theend effector20.
• Thesurgical device10 can also include one or more tissue manipulators associated therewith. The tissue manipulator(s) are generally configured to engage tissue to enable tissue to be positioned within the tissue receiving cavity of the end effector and can have a variety of configurations. One having skill in the art will appreciate that the tissue manipulators described herein are exemplary and that any type of tissue manipulator, and even multiple types of tissue manipulators, can be used with any embodiment described herein. Tissue manipulators useful with the devices and methods disclosed herein can be of any type as long as they are effective to grasp tissue in some manner and move it from a first position to a second position or otherwise assist in the reconfiguration of the tissue. By way of non-limiting example, such tissue manipulators include those that are able to grasp tissue by penetrating the tissue (e.g., a corkscrew or a hook) and those that are able to grasp tissue without penetrating the tissue (e.g., vacuum-assisted graspers and pinching devices).
• As shown inFIG. 2, theend effector20 can include a plurality oftissue manipulators40 that extend distally from thebody22 within thetissue receiving cavity26. While asingle tissue manipulator40 can be utilized for engaging tissue between thejaws24, using two ormore engagement members40 can allow the creation of a tissue fold “line,” rather than a “tent.” For example, rather than engaging thecavity wall6 at a single location, an end effector having multiple tissue manipulators can be effective to grasp tissue at two spaced locations and can create a tissue fold having an increased area in which to place one or more fasteners, thereby decreasing the number of acquisitions or “bites” required for obtaining a fold of the desired length and depth.
• The tissue manipulators40 can include aproximal shaft42 and adistal tip44 disposed thereon. Theproximal shaft42 of eachtissue manipulator40 can extend from thetissue receiving cavity26 proximally through thebody22 of theend effector20 and can be actuated and/or coupled to an actuator for actuating thetissue manipulator40. By way of example, theproximal shaft42 of thetissue manipulators40 can be coupled to control cables that extend through theelongate shaft12 to an actuating assembly disposed at the proximal end of thesurgical device10. Through actuation of the control cables, eachtissue manipulator40 can be actuated to rotate about its longitudinal axis, to be axially advanced, and/or to be axially retracted within and beyond thetissue receiving cavity26. Thetissue manipulator shaft42 can also be flexible, semi-flexible, or rigid, and portions of theshaft42 can have different flexibilities. For example, a length of theshaft42 between thedistal tip44 and thebody22 of theend effector20 can be semi-flexible to allow thetissue manipulator40 to bend outward as thedistal tip44 penetrates tissue, and retract back between thejaws24 as thetissue manipulator40 is axially retracted, to pull the acquired tissue within thetissue receiving cavity26.
• The distal tip of the tissue manipulator can also have a variety of configurations to enable the tissue manipulator to engage, penetrate, and/or grip tissue, and retain the engagement with the tissue as the tissue fold is formed within the tissue receiving cavity. For example, as best shown inFIGS. 4A and 4B, each of thedistal tips44 of thetissue manipulators40 can be of a corkscrew design to allow thedistal tip44 to be “drilled” into tissue. The corkscrew, for example, can be a helical, coring needle having a rounded end with sharpened edges. As will be appreciated by a person skilled in the art, the size of thedistal tips44 can vary depending upon the desired tissue pulling strength.
• The surgical instrument can also include a stabilization element for controlling the lateral displacement and/or flexion of the tissue manipulator. Additionally, the stabilization element can be effective to support the end effector (e.g., maintaining the tissue receiving cavity during operation). For example, as shown inFIGS. 4A,4B, and5, the stabilization element can be ahousing80 located within thetissue receiving cavity26. Thehousing80 can include one or more radially spaced bores82 through which ashaft42 of thetissue manipulators40 can extend. Thehousing80 can be moveably coupled to thejaws26. For example, thehousing80 can include radially extendingflanges84 that are configured to slide within a track28 (e.g., a longitudinally extending slot) formed at least partially within the inner surfaces of thejaws24. Accordingly, as thetissue manipulator40 is retracted within thetissue receiving cavity26, theshaft42 anddistal tip44 of thetissue manipulator40 can move proximally relative to thejaws24 until thedistal tip44 abuts a distal surface of thestabilization element80. Further proximal movement of thetissue manipulator40 can cause proximal movement of thehousing80 relative to thejaws24 as theflanges84 of thehousing80 slide through thetracks28. Such a configuration can thereby stabilize thetissue manipulators40 and reduce their lateral displacement throughout the formation of thetissue fold8. In one aspect, the axial depth of thehousing80 can be minimized in order to maximize the obtainable depth of thetissue fold8. Thehousing80 and orbody22 of theend effector20 can also include a mating feature to enable thehousing80 to recess fully into thebody22 of theend effector20 at the proximal end of the housing's reciprocal path, in order to keep the guide from impinging on the available tissue fold depth.
• Thesurgical device10 can also be associated with a fastener that is configured to secure adjacent layers of tissue that form the tissue fold. WhileFIG. 2 depicts thesurgical device10 associated with afastener60 for applying T-Tag type suture anchors, a person skilled in the art will appreciate that any tissue fastener, or technique for fastening tissue, known in the art and modified in accord with the teachings herein can be used to more permanently secure a tissue fold. In general, the tissue anchors deployed by the fastener can easily be placed into or through tissue, but can be reconfigured following deployment to an altered configuration in which at least one dimension of the tissue anchor is sufficiently large to maintain the tissue anchor in place. Various tissue anchors which are suitable for securing the tissue folds include, but are not limited to, simple suture knots, reconfigurable “basket”-type anchors (which generally comprise a number of configurable struts or legs extending between two collars or support members), and linear anchors (elongate anchors which are configured to fold or become compressed into a bowed or expanded configuration). Additionally, as will be discussed in detail below, the fastener can be configured to deliver energy to the tissue fold to secure adjacent layers of tissue that form the tissue fold, alternatively or in addition, to the application of a mechanical tissue anchor.
• With specific reference toFIG. 3, the fastener associated with thesurgical instrument10 can be a sutureanchor deployment device60 configured to deploy tissue anchors70 through the adjacent layers of tissue that form thetissue fold8. An elongated,tubular housing62 can extend distally from outside the patient and can have a sufficient length to enable the delivery of the sutureanchor deployment device60 through a natural orifice (e.g., the oral cavity) or surgical opening. The sutureanchor deployment device60 can also include a handle and triggering assembly (not shown) remotely operable from outside the body for controlling the discharge of the tissue anchors70. The sutureanchor deployment device60 can also include aneedle64 having a slotted lumen that extends proximally from the sharpened tip through the sutureanchor deployment device60 for retaining the tissue anchors70. Theneedle64 can retain and deploy one or more tissue anchors70, with the particular number of anchors loaded into the needle depending on the selected deployment scheme. For example, the tissue anchors70 can be stacked such that thesuture72 from eachtissue anchor70 exits thetissue anchor70 near the midsection and perpendicular to the axis of thetissue anchor70 and is connected to thesubsequent tissue anchor70. The tissue anchors70 andneedle64 can be aligned so that thesuture72 from the tissue anchors70 also passes through theneedle64. After the tissue anchors70 are deployed through thetissue fold8, thesuture72 can be tightened to pull the tissue anchors70 together on opposite sides of the tissue fold to cinch the tissue fold and draw the adjacent serosal layer within the tissue fold together. Exemplary suture anchor deployment devices, tissue anchors, and methods of tissue apposition using these devices are described in more detail in U.S. Patent Publication No. 2009/0024163 entitled “Hybrid Endoscopic/Laparoscopic Method for forming Serosa-to-Serosa Plications in a Gastric Cavity,” filed on Jul. 18, 2007, which is hereby incorporated herein in its entirety.
• Again referring toFIG. 2, the sutureanchor deployment device60 can optionally be coupled to anoptical endoscope68. For example, the sutureanchor deployment device60 can be coupled adjacent the distal end of theoptical endoscope68 by aring retainer66 such that the sutureanchor delivery device60 can move in conjunction with theoptical endoscope68. By attaching the sutureanchor deployment device60 to theoptical endoscope68, the sutureanchor deployment device60 can move separately from and relative to theend effector20 such that the sutureanchor deployment device60 can be positioned at multiple locations and angles relative to atissue fold8 disposed within thetissue receiving cavity26. The sutureanchor deployment device60 can thus be effective to deploy tissue anchors70 at multiple locations along the depth or length of atissue fold8 without the need to reacquire tissue or to adjust the position of the tissue within thetissue receiving cavity26. The relative movement between the sutureanchor deployment device60 and theend effector20 can also enable the suture anchors to be deployed at substantially a 90° angle relative to thetissue fold8, thereby allowing the tissue anchors70 to more fully penetrate the tissue layers to provide a more secure tissue fold. Further, by enabling independent articulation of the sutureanchor deployment device60 and theoptical endoscope68 relative to theend effector20, the user of the system can have improved visualization of the tissue acquisition and fastening. Alternatively or in addition, separate control members can be connected to the sutureanchor deployment device60 for independently articulating the sutureanchor deployment device60. These control members can be operated from external of the patient's body, in conjunction with the trigger assembly of the sutureanchor deployment device60, and can allow the sutureanchor deployment device60 to be articulated in multiple directions to deploy tissue anchors70 throughout thegastric cavity4.
• Sutures or tissue anchoring devices deployed into and/or through the gastric cavity wall can occasionally fail by being pulled out of the tissue due to contact pressure between the tissue anchor and the secured tissue. This tendency is particularly acute when tension is consistently applied to the tissue anchors by large food volumes caused by patient non-compliance with dietary requirements. To reduce the potential for failure of the tissue anchors, a buttressing device can also be used in conjunction with the tissue anchors. The buttressing device can distribute the load from the tissue anchors across a wider area of the cavity wall, thereby reducing the possibility that tension on the tissue anchor will pull the tissue anchor through the cavity wall. The buttressing device, as well as the tissue anchors themselves, can also be comprised of materials that permit the delivery of therapeutic agents that promote healing, prevent infection, reduce nausea, prevent erosion, induce weight loss, or otherwise provide the patient with a beneficial outcome. The therapeutic agent may be disposed in the implant so as to diffuse or degrade over time in order to advance the treatment or promote healing. Exemplary medicinal agents which can be used with the devices and methods discussed herein are described in more detail in U.S. Pat. No. 7,217,425 entitled “Autologous coatings for implants,” issued on May 15, 2007, which is hereby incorporated herein in its entirety. Exemplary medicinal agents for use with the present device and methods can include, for example, Topomax® brand topiramate, available from Ortho-McNeil Neurologics, Inc. of Titusville, N.J. Topiramate can reduce the need for food and can be used as an adjunct to the surgical procedure. One skilled in the art will appreciate that oral medications can also be used to supplement these effects and that these combination therapies may promote synergies that ultimately greatly increase the efficacy of the surgical procedure.
• In use, thesurgical device10 can be inserted into the gastric cavity to form one or more endoluminal plications or tissue folds. As shown inFIG. 1, theend effector20 can be passed throughovertube2 into the interior of thegastric cavity4. Theoptical endoscope68, with the sutureanchor deployment device60 attached to its distal end, can also be passed transesophageally into thegastric cavity4 through theovertube2. As shown in more detail inFIG. 2, theoptical endoscope68 can provide visualization and illumination to enable the surgeon to position theend effector20 to the desired surgical site within thegastric cavity4. With thejaws24 positioned adjacent thecavity wall6, the tissue manipulator(s)40 can be advanced from between thejaws24 into contact with thecavity wall6. The tissue manipulators40 can be rotated, for example, while simultaneously being advanced in order to puncture and engage thecavity wall6.
• With reference to theexemplary end effector20 shown inFIGS. 4A and 4B, after a section of thecavity wall6 has been acquired by the tissue manipulators40 (FIG. 4A), thetissue manipulators40 can be retracted to pull the tissue of thecavity wall6 into thetissue receiving cavity26 to form atissue fold8, as shown inFIG. 4B. As thetissue manipulators40 are advanced and retracted within thetissue receiving cavity26, thehousing80 can also be advanced and retracted through the sliding of theflanges84 through thetrack28 formed in the inner surface of thejaws24. The corresponding movement of thehousing80 with thetissue manipulators40 can control the outward flexing of thetissue manipulators40 and can draw thetissue manipulators40 back within thetissue receiving cavity26 as thetissue manipulators40 are retracted proximally.
• As shown inFIG. 5, to fasten thetissue fold8, the sutureanchor deployment device60 can be positioned relative to thetissue fold8 retained within thetissue receiving cavity26 to apply atissue anchor70 therethrough. When inserting thetissue anchor70 through thetissue fold8, it can be desirable to have as close to normal an angle as possible between theneedle64 and the targeted surface of thetissue fold8. As shown inFIG. 5, the sutureanchor deployment device60 can be moved in conjunction with theoptical endoscope68 to provide visualization of the targeted location of thetissue anchor70. Additionally or alternatively, vacuum assist can be applied to draw the targeted fold surface against the face of the tissue anchor deployment device just prior to deployment of the tissue anchor. By way of non-limiting example, the vacuum assist can be applied through a working channel of theoptical endoscope68 or a vacuum tube that can run along the elongated,tubular housing62. In addition to movement with theoptical endoscope68, the sutureanchor deployment device60 can be separately articulated from theoptical endoscope68 to place the sutureanchor deployment device60 at the desired location.
• With further reference toFIGS. 5 and 6, once the sutureanchor deployment device60 has been positioned at the desired location, theneedle64 can be inserted through thetissue fold8. Thetissue anchor70 can be released through theneedle64 to pass thetissue anchor70 and its attachedsuture72 through thetissue fold8. After theinitial tissue anchor70 is deployed, the sutureanchor deployment device60 can optionally be moved to additional locations of thetissue fold8 to further secure thetissue fold8 with additional tissue anchors70. After the desired number of tissue anchor(s)70 have been deployed, thesuture material72 for the tissue anchor(s)70 can be cinched together, for example, via a working channel of theoptical endoscope68. The number of tissue anchor(s)70 used to form a tissue fold will depend upon the desired length for the fold and the desired spacing between the tissue anchor(s)70. In one embodiment, the tissue anchor(s)70 can be evenly spaced along the length of the desired tissue fold line to form a uniform tissue fold without distortion or bunching. As well, in one aspect, the same number and spacing of suture anchoring devices is deployed into each tissue fold section so that a uniform fold depth is created along thecavity wall6. The proper relative spacing of the suture anchoring devices can be ascertained, for example, through theoptical endoscope68. Alternatively, a trocar can be inserted into the abdominal wall and used in conjunction with an optical endoscope to visually determine the proper locations for the tissue anchors laparoscopically.
• After thetissue fold8 has been secured, thetissue fold8 can be released from thetissue receiving cavity26 by disengaging thetissue manipulators40 from thecavity wall6. For example, thetissue manipulators40 can be extended and/or rotated in the opposite direction from when penetrating thecavity wall6. The reverse rotation of thetissue manipulators40 can withdraw thedistal tips44 from thecavity wall6, thereby releasing thetissue fold8 from engagement. After thetissue fold8 is released, theend effector20 can also be withdrawn such that thesecured tissue fold8 is no longer positioned within thetissue receiving cavity26.
• In one aspect, after atissue fold8 has been secured, theend effector20 can be repositioned adjacent thetissue fold8. The tissue manipulators40 can then engage the adjacent section of thecavity wall6 and pull the additional wall section within thetissue receiving cavity26. By repositioning theend effector20 on either side of the previously formed tissue fold, and repeating the tissue engaging and securing steps, the length of thetissue fold8 can be extended on either side of the initial fold. Additional tissue anchors70 can be deployed to secure each additional section of thetissue fold8 until the desired fold length along thecavity wall6 is achieved. In addition to repeating the plicating procedure to extend the length of theinitial fold8, theend effector20 can be repositioned to different locations within thegastric cavity4 to form separate tissue folds at distinct points within thecavity4.
• FIG. 6 depicts asecured tissue fold8 resulting from process described above. As shown inFIG. 6, a pair of tissue anchors70 have been deployed in two separate rows to form aninvoluted fold8 in the anterior wall of thegastric cavity4. As thetissue fold8 is involuted into the interior of thegastric cavity4, the outer serosal layer of thecavity wall6 can be drawn into contact with itself in the interior of thetissue fold8. The tissue anchors70 can be pulled together by the attachedsuture72, and the tension in thesuture72 locked in by a slip knot, knotting element, or other type of suture knot. The tissue anchors70 placed through thecavity wall6 can thus maintain the serosa-to-serosa contact within thetissue fold8 during healing. As can be seen by comparing the dashed line with the solid line boundary of the stomach, thetissue fold8 can reduce the effective volume of thegastric cavity4 and can provide many of the advantages mentioned above.
• In addition to use of a buttressing device, as discussed above, the opposed serosal layers in contact on the interior of thetissue fold8 can be treated to reinforce thetissue fold8. For example, the treatments can promote healing between the contacting serosal surfaces. By way of non-limiting example, the treatment can include abrasion, thermal damage, electrical damage or chemical damage to create scar tissue along the serosal surface. When the treated tissue areas are joined together into a fold, the treatment can induce an earlier and more rapid healing response that may also serve to promote a stronger, more durable bond between the serosal layers. The serosa-to-serosa fold can also be reinforced by injecting a chemical solution into the tissue that forms the tissue fold. The injected solution can toughen the surrounding tissue area to decrease the likelihood that the tissue anchors erode and/or pull through the cavity wall. Suitable chemical solutions (or bulking agents) can include, for example, schlersoants, TGF-beta, keratin, PMMA (polymethyl-methacrylate). Medications that promote healing, such as Vitamin C can also be used to aid in the serosa-to-serosa healing. Such medications can be taken orally, or additionally or alternatively, can be delivered through the tissue anchors or buttress, for example.
• As discussed above, the end effector for use with the surgical instrument of the present invention can have a variety of configurations. For example,FIGS. 7A-7C depict another embodiment of an end effector that can be used to create an endoluminal tissue fold. Theend effector720 is substantially similar to theend effector20, described above, and includes opposedjaws724 that can define atissue receiving cavity726 therebetween. Theopposed jaws724 can extend distally from thebody722 of theend effector720. Though the distal ends of thejaws724 do not flare outward, the distal ends can be substantially rounded to prevent accidental penetration of thecavity wall6 with theend effector720. Thebody722 of theend effector720 can also define a bore therethrough that allows an axially extendable andretractable tissue manipulator740 to extend into thetissue receiving cavity726.
• In use, theend effector720 can be delivered to the desired surgical site (e.g., within the gastric cavity) and positioned adjacent thecavity wall6. Thetissue manipulator740 can be extended to engage thecavity wall6, as shown inFIG. 7A. For example, thetissue manipulator740 can be axially extended and rotated such that thedistal tip744 of thetissue manipulator740 is screwed into thecavity wall6. Following engagement of thecavity wall6 with thetissue manipulator740, a tissue fold can be initiated by axially retracting thetissue manipulator740 with thecavity wall6 coupled thereto, as shown inFIG. 7B. Though the adjacent layers of the tissue that form thetissue fold8 can be secured at any point, the depth of the tissue fold can be maximized by fully retracting thetissue manipulator740 such that the depth of thetissue fold8 is substantially equal to the length of thetissue receiving cavity726, as shown inFIG. 7C. As discussed above, once thetissue fold8 is positioned within thetissue receiving cavity726, thetissue fold8 can be secured using a fastener associated with theend effector720.
• FIGS. 8A-8C depict another embodiment of an end effector that can be used to create an endoluminal tissue fold. Theend effector820 is substantially similar to theend effector720, depicted inFIGS. 7A-7C, except that theopposed jaws824 can be extended to increase the length of thetissue receiving cavity826, thereby enabling additional tissue to be pulled between thejaws824 to increase the depth of thetissue fold8. Accordingly, theend effector820 can have an initial, minimum length as required for delivery to the desired surgical site. After delivery to the desired surgical site (e.g., within the gastric cavity), thejaws824 can be lengthened. By way of non-limiting example, thejaws824 can includetelescoping extension members830 moveably coupled to the surface of thejaws824 that face thetissue receiving cavity826. Thetelescoping members830 can also be coupled to an actuator (e.g., a pulley, push rod, etc.) that can be effective to move thetelescoping members830 distally relative to the body822 of theend effector820, thereby increasing the length of thejaws824 and thetissue receiving cavity826. As the length of thejaws824 and thetissue receiving cavity826 is increased, the maximum obtainable depth of thetissue fold8 can be increased as a greater volume of tissue can be drawn into thetissue receiving cavity826.
• In one aspect, theend effector820 can be substantially rigid or semi-rigid in order to support the formation of the tissue fold. Accordingly, the rigidity of theend effector820 can restrict the maximum length of theend effector820 in order to deliver theend effector820 to the desired surgical site through a tortuous body lumen of a limited diameter. Thus, as shown inFIG. 8A, theend effector820 can have a maximum rigid length in the delivery configuration (R_D) that can be minimized to ease delivery to the surgical site. After being positioned at the surgical site, the maximum rigid length of theend effector820 can be increased, for example, by extending thetelescoping jaws824. Upon manipulating theend effector820, the maximum rigid length of theend effector820 can be increased to a second maximum rigid length in the treatment configuration (R_T), as shown inFIG. 8C. This extension of thetelescoping jaws824 can be effective to create atissue fold8 having a depth (D) that is greater than the maximum rigid length of theend effector820 in the delivery configuration (R_D).
• In use, theend effector820 can be delivered to the desired surgical site (e.g., within the gastric cavity) in a delivery configuration, as shown inFIG. 8A. After being positioned adjacent thecavity wall6, thetissue manipulator840 can be extended to engage thecavity wall6. For example, thetissue manipulator840 can be axially extended and rotated such that thedistal tip844 of thetissue manipulator840 can be screwed into thecavity wall6. Following engagement of thecavity wall6 with thetissue manipulator840, atissue fold8 can be initiated by axially retracting thetissue manipulator840 within thetissue receiving cavity826 having a first length (L_D) in the delivery configuration, as shown inFIG. 8B. Alternatively, as will be discussed below, the tissue fold can be initiated by extending thetelescoping jaws824. As shown inFIG. 8C, thetelescoping jaws824 can then be extended from their delivery configuration to a treatment configuration in which the length (L_T) of thetissue receiving cavity826 is greater than the first length (L_D). Though the adjacent layers of the tissue that form thetissue fold8 can be secured at any point, the depth of thetissue fold8 can be maximized by fully retracting thetissue manipulator840 such that the depth (D) of thetissue fold8 is substantially equal to the length (L_T) of thetissue receiving cavity826 in the treatment configuration, as shown inFIG. 8C. As discussed above, thetissue fold8 can then be secured using a fastener associated with theend effector820. Thejaws824 can be telescoped back to their original length for removal or repositioning of theend effector820.
• FIGS. 9A-9C depict another embodiment of an end effector that can be used to create an endoluminal tissue fold. Theend effector920 is substantially similar to theend effector820, depicted inFIGS. 8A-8C, except that thetelescoping extension members930 can be movably coupled to the outer surfaces of theopposed jaws924. Accordingly, as shown inFIG. 9A, thetelescoping members930 can have a maximum length that is substantially equal to the maximum rigid length of theend effector920 in the delivery configuration. As above, thetelescoping members930 can be extended to increase the length of thetissue receiving cavity926 from a first length in the delivery configuration (L_D) to a second length in the treatment configuration (L_T), thereby increasing the maximum obtainable depth of the tissue fold.
• In use, theend effector920 can form atissue fold8 substantially as discussed above in reference toFIGS. 8A-8C. Alternatively, theend effector920 can be delivered to the desired surgical site (e.g., within the gastric cavity) in a delivery configuration, as shown inFIG. 9A. After being positioned adjacent thecavity wall6, thetissue manipulator940 can be extended to engage thecavity wall6. Following engagement of thecavity wall6 with thetissue manipulator940, atissue fold8 can be initiated by extending thetelescoping jaws924 from their delivery configuration to a treatment configuration, as shown inFIGS. 9B and 9C. Theend effector920 can have a maximum rigid length (R_T) in the treatment configuration that is greater than the maximum rigid length (R_D) in the delivery configuration. Thetissue manipulator940 can then be retracted within thetissue receiving cavity926 having the second length (L_T) in the treatment configuration, as shown inFIG. 9D. Though the adjacent layers of the tissue that form thetissue fold8 can be secured at any point, the depth of thetissue fold8 can be maximized by fully retracting thetissue manipulator940 such that the depth (D) of thetissue fold8 is substantially equal to the length (L_T) of thetissue receiving cavity926 in the treatment configuration, as shown inFIG. 9D. As discussed above, thetissue fold8 can then be secured using a fastener associated with theend effector920. Thejaws924 can be telescoped back to their original length for removal or repositioning of theend effector920.
• FIG. 10 depicts another embodiment of an end effector that can be used to create an endoluminal tissue fold. Theend effector1020 is substantially similar to theend effector920 described above with reference toFIGS. 9A-9D, except that theend effector1020 additionally includes a stabilization element for controlling the lateral displacement and/or flexion of the tissue manipulator. For example, the stabilization element can be ahousing1080 located within thetissue receiving cavity1026 and movably coupled to thetelescoping jaws1024. Thehousing1080 can include a bore through which a portion of thetissue manipulator1040 can extend. As will be appreciated by a person skilled in the art, thehousing1080 can be coupled to thetissue manipulator1040 such that it is moveable with and/or independent of thetissue manipulator1040. Additionally, thehousing1080 can be movably engaged with thetelescoping jaws1024 through the cooperation of features formed on thehousing1080 andtelescoping jaws1024. For example, thehousing1080 can include one ormore grooves1084 on the surfaces facing thetelescoping jaws1024. Thetelescoping jaws1024 can also include a corresponding number ofribs1028 that extend longitudinally along the inner surface of theopposed jaws1024. Accordingly, as thetissue manipulator1040 is retracted within thetissue receiving cavity1026, theribs1028 can create a track upon which thegrooves1084 of thehousing1080 can slide. In one aspect, the axial depth of thehousing1080 is minimized in order to maximize the obtainable tissue fold depth. Thebody1022 of theend effector1020 can also include arecess1032 to enable thehousing1080 to recess fully into thebody1022 of theend effector1020 at the proximal end of the housing's reciprocal path.
• FIGS. 11A-11C depict another embodiment of an end effector that can be used to create an endoluminal tissue fold. Theend effector1120 is substantially similar to theend effector720 described above with reference toFIGS. 7A-7C, except that theend effector1120 additionally includes a stabilization element for controlling the lateral displacement and/or flexion of the tissue manipulator. As shown inFIGS. 11A-11C, the stabilization element can be asheath1180 disposed substantially around theend effector1120 and moveably coupled thereto. Thesheath1180 can define a lumen through which theend effector1120 can be disposed and adistal surface1186 through which theopposed jaws1124 and thetissue manipulator1140 can extend. Additionally, thesheath1180 can be coupled to thetissue manipulator1140 such that movement of thesheath1180 can be effective to cause corresponding movement of thetissue manipulator1140 and vice versa. Thus, theend effector1120 can be delivered to the surgical site in a delivery configuration with thesheath1180 disposed therearound, as shown inFIG. 11A. Accordingly, thejaws1124 of theend effector1120 can be disposed substantially within thesheath1180 such that thetissue receiving cavity1126 has a length in the delivery configuration of substantially zero. That is, until thesheath1180 is proximally retracted, thejaws1124 are within thesheath1180 such that there is not a space within theend effector1120 in which to receive tissue. After engaging thecavity wall6 with thetissue manipulator1140, atissue fold8 can be initiated by manipulating theend effector1120 by proximally retracting thesheath1180 and thetissue manipulator1140 such that thecavity wall6 is pulled into thetissue receiving cavity1126 between the exposedjaws1124 of the end effector, as shown inFIG. 11B. Though the adjacent layers of the tissue that form thetissue fold8 can be secured at any point, the depth of thetissue fold8 is typically maximized by fully retracting thesheath1180 and thetissue manipulator1140 until thetissue manipulator1140 andsheath1180 are in their fully retracted position, as shown inFIG. 11C. A person skilled in the art will appreciate that theend effector1120 can also include additional features described herein. For example, thejaws1124 of theend effector1120 can be configured to extend from the distal end of thesheath1180 as discussed above with respect toFIGS. 8A-8C and9A-9D.
• FIGS. 12A and 12B depict another embodiment of an end effector effective to create an endoluminal tissue fold. Theend effector1220 can include abody1222 having first andsecond arms1224a,1224bextending distally therefrom. The first andsecond arms1224a,1224bcan be coupled to the distal end of thebody1222 of theend effector1220, or alternatively, can extend through thebody1222 of theend effector1220, e.g., via a bore formed within thebody1222. The first andsecond arms1224a,1224bcan also be effective to define atissue receiving cavity1226 therebetween. As discussed above, theend effector1220 can include atissue manipulator1240 associated therewith that is configured to engage tissue within thetissue receiving cavity1226.
• The first andsecond arms1224a,1224bof theend effector1220 can have a variety of configurations, but as shown inFIG. 12A, thefirst arm1224acan be substantially similar to one of thearms24 depicted inFIGS. 4A-4C. That is, thefirst arm1224acan be substantially rigid and fixedly coupled to thebody1222 of theend effector1220 such that thefirst arm1224acannot move relative to thebody1222 of theend effector1220. Thesecond arm1224bcan be a segmented arm that is formed from a plurality ofconnected link segments1234. Theconnected link segments1234 can be coupled to one another such that thesegmented arm1224bcan be moved between a flexible configuration as shown inFIG. 12A, and a rigid configuration as shown inFIG. 12B. In the flexible configuration, the plurality ofconnected link segments1234 can be coupled such thatadjacent segments1234 can move relative to one another. By way of non-limiting example, the plurality ofconnected link segments1234 can be coupled together via a joint, such as a flexible portion, hinge, or spring. In the rigid configuration, however, theconnected link segments1234 can be coupled such thatlink segments1234 form a rigid segmented arm, such as in a linear configuration, as depicted inFIG. 12B.
• Thesegmented arm1224bcan also include an actuator configured to move thesegmented arm1224bfrom the flexible configuration to the rigid configuration. For example, the actuator can be in the form of aflexible cable1236 that can pass through each of theconnected link segments1234. Thecable1236 can extend proximally from the mostdistal link segment1234 to outside the patient's body to allow the user to tension thecable1236. By actuating thecable1236, theconnected link segments1234 can be pulled together such that theconnected link segments1234 are substantially fixed relative to one another, thereby forming a rigidsegmented arm1224b. Alternatively, the actuator can be in the form of a rigid shaft that can be inserted through theconnected link segments1234 such that thesegmented arm1224bassumes the rigid configuration.
• In use, theend effector1220 can be delivered to the desired surgical site (e.g., within the gastric cavity) and positioned adjacent thecavity wall6 with thesegmented arm1224bin the delivery configuration as shown inFIG. 12A. Because theconnected link segments1234 can be flexibly connected in the delivery configuration, the segmented arm can pass more easily through the tortuous body lumen than a rigid member of the same length. Thetissue manipulator1240 can then be extended to engage thecavity wall6. Following engagement of thecavity wall6 with thetissue manipulator1240, atissue fold8 can be initiated by axially retracting thetissue manipulator1240 with thecavity wall6 coupled thereto. Before, during, and/or after manipulating the tissue by retracting thetissue manipulator1240 with thecavity wall6 coupled thereto, theend effector1220 can be moved from the delivery configuration to the treatment configuration. For example, thecable1236 can be actuated to rigidize thesegmented arm1224bsuch that theconnected link segments1234 become substantially fixed relative to one another. As thecable1236 is tensioned, the plurality of connected linkedsegments1234 can align such that the segmented arm becomes substantially rigid and parallel with thefirst arm1224a, as shown inFIG. 12B. As the segmented arm moves into the treatment configuration, thesegmented arm1224bcan capture thecavity wall6 engaged with thetissue manipulator1240 such that atissue fold8 is formed in thetissue receiving cavity1226 defined by thefirst arm1224aand the rigidsegmented arm1224bin the treatment configuration. The depth of thetissue fold8 is typically maximized by fully retracting thetissue manipulator1240 such that the depth of thetissue fold8 is substantially equal to the length of thetissue receiving cavity1226, as shown inFIG. 12B. As discussed above, once thetissue fold8 is positioned within thetissue receiving cavity1226, thetissue fold8 can be secured using a fastener associated with theend effector1220.
• Although only thesecond arm1224bis depicted as being segmented inFIGS. 12A and 12B, both the first andsecond arms1224a,1224bcan be segmented. Accordingly, the rigid length of theend effector1220 can be defined as the maximum dimension of the longest rigid segment of theend effector1220 in the delivery configuration (i.e., wherein both of the segmented arms have a rigid length less than their full length due to the ability of theconnected link segments1234 to flex relative to one another). Accordingly, the length of thetissue receiving cavity1226 between thesegmented arms1224a,1224bin the treatment configuration, and thus the depth of thetissue fold8, can be greater than the maximum rigid length of theend effector1220 in the delivery configuration.
• FIGS. 13A and 13B depict another embodiment of a surgical device for forming an endoluminal tissue fold. As shown inFIGS. 13A and 13B, the surgical device can include anend effector1320 having afirst arm1324aand asteerable arm1324b. Thefirst arm1324acan be a flat, longitudinally extending arm that can be configured to extend distally from the distal end of theelongate shaft1312. Thefirst arm1324acan be made of a material to resist deflection, or can be composed of a shape memory material such as, for example, Nitinol, which can expand outward as the arm is extended distally. At least onetissue manipulator1340 can also extend distally from theelongate shaft1312 for acquiring and/or engaging tissue of thecavity wall6. As in previous embodiments, thetissue manipulator1340 can be actuated to advance, retract and rotate relative to thefirst arm1324a, in order to acquire and draw tissue proximally and against thefirst arm1324a.
• Theend effector1320 can also include asteerable arm1324bthat can be used in conjunction with thefirst arm1324ato manipulate and stabilize the tissue to form atissue fold8. Thesteerable arm1324bcan be steered within thegastric cavity4 via acable1336 that can be attached at one or more points of thesteerable arm1324b. Thecable1336 can provide support and/or control of thesteerable arm1336 during the formation of atissue fold8 within a tissue receiving cavity1326 between thesteerable arm1324band the fixedarm1324aand/or during deployment of thetissue anchor1370 through thetissue fold8. The distal end of thecable1336 can be attached to the distal end of thesteerable arm1324b, while the proximal end of thecable1336 can extend through theshaft1312 to provide control of thesteerable arm1324bexternal of the patient.
• As will be appreciated by a person skilled in the art, thecable1336 can be coupled to the endoscope in any manner known in the art. As shown, thecable1336 can be attached to thesteerable arm1324bby elastomeric connectors1334a-c. The connectors1334a-ccan be disposed around thesteerable arm1324b, for example, at a plurality of locations to facilitate control of thesteerable arm1324b. For example, as shown inFIG. 13A, afirst connector1334acan be disposed around the distal end of thesteerable arm1324b, asecond connector1334bcan be disposed around the steerable arm adjacent the distal end of theelongate shaft1312, and athird connector1334ccan be disposed around thesteerable arm1324bat a location between thefirst connector1334aand thesecond connector1334b. Thecable1336 can extend between the connectors1334a-cand proximally through theelongate shaft1312 to enable the user to tension thecable1336 to enable thesteerable arm1324bto assume an “S” configuration. This “S” configuration in conjunction with the steering of the distal end of thesteerable arm1324benables thesteerable arm1324bto abut thetissue fold8 at substantially at a normal angle. Thesteerable arm1324bcan assume the “S” configuration, for example, by drawing thecable1336 taut between the connectors1334a-c.
• The connectors1334a-ccan be connected to thesteerable arm1324bprior to insertion of theend effector1320 into thegastric cavity4, and they can include a tear away feature for removing the connectors1334a-cfrom the endoscope following completion of the procedure. Connectors (and the tear away feature) for use with the present invention are described in greater detail in US Patent Application Publication Number 2008/0103357, entitled “Attachment Apparatus for an Endoscope,” published May 1, 2008, which is hereby incorporated herein in its entirety by reference.
• Thecable1336 and connectors1334a-cprovide only one possible means for flexing thesteerable arm1324binto an “S” shape for coordinating with thefirst arm1324ato form thetissue fold8. As will be appreciated by one skilled in the art, a number of different types of methods also exist for similarly controlling thesteerable arm1324binto a similar configuration. For example, the placement of various objects, including, among others, a balloon, wedge or hinge, between thesteerable arm1324band fixedarm1324afor pushing thesteerable arm1324baway from thefirst arm1324aproximal to the distal opening of thesteerable arm1324b.
• Additionally, a working channel extending through thesteerable arm1324bcan allow a suture anchor deployment device (not shown) to pass through thesteerable arm1324b. A fastener, e.g. the sutureanchor deployment device60 described above with reference toFIGS. 1-6, can extend through thesteerable arm1324bsuch that when the distal end of thesteerable arm1324babuts thetissue fold8 at a substantially normal angle, atissue anchor1370 can be deployed to fasten thetissue fold8.
• The distal end of thefirst arm1324acan be closed, such as by a backstop or membrane, to prevent thetissue anchor1370 from penetrating through thefirst arm1324aupon deployment. Alternatively, as shown inFIG. 13B, the distal end of thefirst arm1324bcan include anopening1338 to allow thetissue anchor1370 to be deployed through thefirst arm1324a. In one embodiment, a buttressing material can be included within theopening1338 so that thetissue anchor1370 also penetrates the material during its deployment. After penetration of the material by thetissue anchor1370, the buttressing material can be released from theopening1338 to provide reinforcement to thetissue fold8 and/or to prevent failure of thetissue anchor1370. Additional buttressing material can alternatively or additionally be provided between the distal opening of thesteerable arm1324band thetissue fold8 to reinforce the other side of thetissue fold8.
• FIGS. 14A-14D depict another embodiment of an end effector for use with a surgical device for forming an endoluminal tissue fold. As shown inFIGS. 14A and 14B, theend effector1420 can include a pair ofarms1424 that extend radially outward from atubular body1422. Theend effector1420 can includeend caps1423a,bdisposed on thebody1422 effective to retain the proximal and distal ends of thearms1424. At least one of theend caps1423a,bcan be movable relative to thebody1422 and/or the other end cap such that thearms1424 can be reconfigured based on the relative position of theendcaps1423a,b. For example, theproximal end cap1423acan be moved (e.g., slid along body1422) from a first, proximal position, as shown inFIG. 14A, to a second more distal position, as shown inFIG. 14B. By way of non-limiting example, theend cap1423acan be in the first position during insertion of theend effector1420 into thegastric cavity4 such that thearms1424 assume a low profile configuration in which thearms1424 are adjacent and substantially parallel to thebody1422, as shown inFIG. 14A. This low profile configuration can ease the passage of theend effector1420 through an overtube or other transoral delivery device.
• Once theend effector1420 has been introduced to the gastric cavity, for example, theend effector1420 can be moved into an open, delivery configuration, as shown inFIG. 14B. By way of non-limiting example, theend caps1423a,bcan be compressed, such as by activation of an actuator cable (not shown) that extends through thebody1422, relative to one another such that the arms move from a position proximate to and substantially parallel to thebody1422 to a bowed configuration, as shown inFIG. 14B. In this open, delivery configuration, thearms1424 can be substantially planar (e.g., substantially on the plane defined by the x-axis and y-axis as shown inFIG. 14B) relative to thebody1422 such that thearms1424 andbody1422 can be positioned adjacent the wall of the gastric cavity. Thus, in a delivery configuration, thetissue receiving cavity1426 can have a length (e.g., in the z-axis as shown inFIG. 14B) of substantially zero.
• As will be appreciated by a person of skill in the art, thearms1424 can be formed of any material(s) that allow thearms1424 to be reconfigured from a low-profile configuration to a bowed configuration, such as by the application of a compressive force. By way of non-limiting example, the arms can be formed from a polymeric material, a shape memory material, and/or metals such as stainless steel. In one embodiment, thearms1424 can be comprised of a shape memory material that enables thearms1424 to assist the reconfiguration of theend effector1420.
• An actuating cable can extend through thebody1422, in contact with the distal and proximal ends of thearms1424 to move the arms between the open, delivery configuration and a closed, tissue engaging configuration, as shown inFIG. 14C. By way of non-limiting example, theend caps1423a,bcan be further compressed, such as by activation of an actuator cable, rotating thearms1424 from the bowed position inFIG. 14B to the position shown inFIG. 14C through contact with sloped edges of theend caps1423a,b. A plurality of tissue anchors1470, such as, for example, staples, T-Tag anchors, nitinol springs, etc. can be disposed on a tissue contacting surface of thearms1424 or included within thearms1424. Theopenings1425 can be provided in thearms1424 for releasing the tissue anchors1470 into atissue fold8 formed within thetissue receiving cavity1426.
• Thetubular body1422 can further include an opening1427 into the interior of thebody1422. A tissue manipulator (not shown) can be configured to extend through thetubular body1422 and out of the opening1427 to engage thecavity wall6, as discussed elsewhere herein. Alternatively or additionally, vacuum pressure can be applied through the opening1427 to pull and/or retain tissue therein during deployment of thearms1424. Aneedle1429, shown inFIG. 14D, can also extend through the interior of thebody1422. Theneedle1429 can have sufficient length for advancing into and penetrating tissue drawn into the opening1427 in order to hold the tissue stable within the opening1427. It is conceived that tissue grasping means including but not limited to graspers, corkscrews, hooks, and rollers may secure the tissue in a similar manner as described usingneedle1429.
• In use, theend effector1420 can be delivered to the gastric cavity to form one or more endoluminal tissue folds. For example, the end effector can be inserted through a transoral passage in a low-profile configuration, as shown inFIG. 14A. After being introduced into the gastric cavity, theproximal end cap1423acan be slid distally relative to thedistal end cap1423bsuch that thearms1424 assume the open, delivery configuration shown inFIG. 14B. With thearms1424 in the open configuration, the tissue manipulator can be introduced into thegastric cavity4 through the opening1427. The tissue manipulator can be actuated to engage thecavity wall6 and subsequently retracted to draw a portion of thecavity wall6 into the opening1427. Vacuum pressure can be applied to further draw the tissue layers into the opening1427, as shown inFIG. 14D. Additionally, theneedle1429 can be advanced into and through the tissue drawn into the opening1427 to lock the tissue therein. With thetissue cavity wall6 secured within the opening1427, thearms1424 can be moved from the open, delivery configuration to the closed configuration as shown inFIG. 14C to thereby capture a section of thecavity wall6 within thetissue receiving cavity1426. For example, as the arms move from the substantially planar delivery configuration, thearms1424 can swing in an arc through thegastric cavity4 and engage a large, circular section of thecavity wall6. As thearms1424 swing together, thearms1424 can draw the wall section together into atissue fold8 within thetissue receiving cavity1426. Tissue anchors1470 can be then be deployed into thetissue fold8 retained between thearms1424 to secure the adjacent layers of tissue that form thetissue fold8. For example, the adjacent serosal layers on the interior of the tissue fold can be secured together. As discussed above, theend caps1423a,bcan be moved relative to one another (e.g., compressed and expanded) in the open, delivery configuration such that thearms1424 can be configured to maximize the depth of thetissue fold8. By way of non-limiting example, as theproximal end cap1423ais moved distally relative todistal end cap1423b, the length (L_T) of thetissue receiving cavity1426 defined by thearms1424 in the tissue engaging configuration can be increased. Following the fastening of thetissue fold8, thearms1424 can be actuated back to their open, delivery configuration. Theneedle1429 can be retracted proximally within thebody1422, and the vacuum disengaged to release the tissue from opening1427. After the tissue is released from theend effector1420, theend cap1423acan be slid proximally relative to thedistal end cap1423bsuch that thearms1424 assume a low profile configuration in which thearms1424 are in longitudinal alignment with thebody1422 such that theend effector1420 can be withdrawn through the overtube.
• FIGS.15 and16A-16C depict another embodiment of a surgical device for forming an endoluminal tissue fold to reduce the volume of the gastric cavity. As shown inFIG. 15, thesurgical device1510 generally includes anend effector1520 disposed on the distal end of aflexible shaft1512, atissue manipulator1540, and a fastener. As discussed above, end effectors for use in the present invention generally include atissue receiving cavity1526 in which a tissue fold can be formed. In the embodiment depicted in FIGS.15 and16A-16C, theend effector1520 can include a flareddistal portion1524 that can define thetissue receiving cavity1526. Additionally, a fastener in the form of a plurality of elastic rings1560a-dcan be stretched and stacked around the outer circumference of the flareddistal portion1524. Pull strings1572a-dcan be looped through an individual corresponding ring1560a-dand can extend proximally through the lumen of theelongate shaft1512 to enable external deployment of the elastic rings1560a-d.
• As discussed above, the tissue manipulator is generally configured to engage tissue to enable tissue to be positioned within the tissue receiving cavity of the end effector and can also have a variety of configurations. As shown, theend effector1520 can also be associated with atissue manipulator1540 that is configured to engage tissue (e.g., the wall of the gastric cavity) to enable the tissue to be positioned within thetissue receiving cavity1526. Thetissue manipulator1540 generally includes aproximal tubular portion1542 and adistal opening1544 through which vacuum pressure can be applied. The vacuum can be effective to draw thecavity wall6 against thedistal opening1544 of thetissue manipulator1540. Thetissue manipulator1540 can be in a fixed position relative to theend effector1520 such that the vacuum is effective to draw the tissue into thetissue receiving cavity1526. Alternatively, as discussed above, thetissue manipulator1540 can be configured to axially extend and retract to capture tissue.
• As shown in the sequence depicted inFIGS. 16A-16C, theend effector1520 can be delivered to the gastric cavity to form one or more endoluminal tissue folds. As shown inFIG. 16A, the distal end of theend effector1520 can be positioned adjacent the desired surgical site. Vacuum pressure applied through thedistal end1544 of thetissue manipulator1540 can be applied to engage thecavity wall6, and thetissue manipulator1540 can be retracted distally within thetissue receiving cavity1526. Alternatively, the vacuum pressure applied by thetissue manipulator1540 can be sufficient to simply draw thecavity wall6 into thetissue receiving cavity1526. That is, thetissue manipulator1540 can manipulate thecavity wall6 simply by drawing thecavity wall6 into thetissue receiving cavity1526, without having to extend and/or retract thetissue manipulator1540. Regardless, when thecavity wall6 is pulled into thetissue receiving cavity1526 to a desired depth, thepull string1572acan be actuated to dislodge thering1560afrom around the perimeter of theend effector1520, as shown inFIG. 16B. As thering1560ais pulled from around the perimeter of theend effector1520, thering1560acan contract inward due to its elasticity such that thering1560aencircles and secures the tissue fold disposed within thetissue receiving cavity1526 to form atissue nodule8, as shown inFIG. 16C. After thetissue nodule8 is secured, the vacuum pressure of thetissue manipulator1540 can be discontinued to release thetissue nodule8 from theend effector1520. Theend effector1520 can subsequently be moved to another targeted section of thecavity wall6 to form another nodule by, for example, pulling a second pull string to release thesecond ring1560baround a second tissue fold disposed within thetissue receiving cavity1526 to form a second tissue nodule.
• Alternatively or in addition to the fasteners discussed above, the surgical devices for forming an endoluminal tissue fold can be associated with a fastener that includes one or more electrodes configured to deliver energy to secure adjacent layers of tissue that form the tissue fold.FIG. 17 depicts one embodiment of an end effector for forming an endoluminal tissue fold that includes an electrode for applying energy to the tissue fold. Theend effector1720 is substantially similar to theend effector720 described above with reference toFIGS. 7A-7C except that theend effector1720 includes two electrodes1760 (one of which can be an active, energy-delivering electrode and the other of which can be a return electrode) disposed on the tissue contacting surface of theopposed jaws1724. Theelectrodes1760 can be configured to contact the outer surfaces of atissue fold8 when thetissue fold8 is disposed within thetissue receiving cavity1726. Though theelectrodes1760 are depicted with reference to theend effector1720, it will be appreciated that any of the embodiments of the surgical device described herein can include electrodes for delivering energy to a tissue fold.
• As will be appreciated by a person skilled in the art, theelectrodes1760 can have various configurations depending on the energy to be applied. By way of non-limiting example, thermal energy, electrical energy, acoustic energy (e.g., ultrasonic), and/or radiofrequency (RF) can be applied by the electrode(s) to the tissue fold to bond the opposed serosal layers in contact on the interior of the tissue fold. Further, the skilled artisan will appreciate that the treatment parameters (e.g., power, energy, delivery time, frequency, wave pattern) and the physical parameters of the energy delivery system (e.g., the number, diameter, spacing, and location of the electrodes) can be optimized to secure the adjacent layers of tissue. The skilled artisan will also appreciate that the surgical device can include an energy source operatively coupled to the electrode(s) to activate the one or more electrode(s). By way of example, the energy source can be a battery disposed within the surgical device, or the surgical device can be adapted to couple to an external energy source, such as a generator or an outlet. Further, the surgical device can include a mechanism to activate the delivery of energy by the electrode(s), such as a button or dial.
• In use, theend effector1720 can be delivered to the desired surgical site (e.g., within the gastric cavity) and positioned adjacent thecavity wall6. As above, following engagement of thecavity wall6 with thetissue manipulator1740, the tissue can be manipulated to form a tissue fold within thetissue receiving cavity1726. With the tissue fold in contact with theelectrodes1760 disposed on a tissue contacting surface of theopposed jaws1724, energy can be delivered to the tissue fold through one or more electrode(s)1760. For example, anelectrode1760, operating in either a bipolar or monopolar mode, can deliver RF energy to the tissue fold such that the adjacent layers of the tissue that form the tissue fold are secured.
• FIG. 18 depicts another embodiment of an end effector for forming an endoluminal tissue fold that includes an electrode for applying energy to the tissue fold. Theend effector1820 is substantially similar to theend effector1720 described above with reference toFIG. 17, excludingelectrodes1760. Instead theend effector1820 is associated withelectrodes1860 that can be moveable between a first position, in which theelectrodes1860 are substantially disposed withinbores1862 through one of theopposed jaws1824, to a second position in which at least portions of theelectrodes1860 extend into the tissue receiving cavity1826. As shown inFIG. 18, theelectrodes1860 can be configured to penetrate at least partially through the adjacent layers of tissue that form thetissue fold8 disposed within the tissue receiving cavity1826. By way of example, theelectrodes1860 can be in the form of a needle configured to pierce the tissue that forms thetissue fold8. Although theneedle electrodes1860 are depicted as being inserted into thetissue fold8 substantially transverse to the central axis of the tissue fold, the electrodes can be configured to be inserted into thetissue fold8 at any angle.
• For example, referring now toFIGS. 19A and 19B, theend effector1920 can includeelectrodes1960 configured to be inserted into thetissue fold8 substantially along the central axis of thetissue fold8. As shown inFIG. 19, theend effector1920 can includeopposed jaws1924a,bdefining atissue receiving cavity1926 therebetween. Theend effector1920 can additionally include a tissue manipulator (not shown) that is configured to engage tissue within thetissue receiving cavity1926, as described elsewhere herein. Theopposed jaws1924a,band thetissue receiving cavity1926 can have a variety of configurations, but as depicted inFIG. 19A, theopposed jaws1924a,bcan be configured to manipulate thetissue fold8 formed within thetissue receiving cavity1926 such that at least a portion of thetissue fold8 is bowed. For example, thefirst jaw1924acan include aprotrusion1931 and thesecond jaw1924bcan include atrough1933 opposed to theprotrusion1931. Accordingly, atissue fold8 disposed within thetissue receiving cavity1926 can bend around theprotrusion1931 and extend into thetrough1933. Theend effector1920 can also includeelectrodes1960 that are substantially disposed within one of the opposed jaws. For example, the secondopposed jaw1924bcan include one ormore bores1962 in which theelectrodes1960 can be disposed. Theelectrodes1960 can be actuated between a first position, in which theelectrodes1960 are substantially disposed within thebores1962, to second position in which at least portions of theelectrodes1960 extend from thebores1962 and into thetissue receiving cavity1926. As shown inFIG. 19B, actuation of theelectrodes1960 can be effective to extend theelectrodes1960 into the bowed portion of thetissue fold8 disposed within thetissue receiving cavity1926 substantially along the longitudinal axis of thetissue fold8 such that one or both of the layers of tissue that form thetissue fold8 are penetrated. Accordingly, theelectrodes1960 can apply energy to the interior of thetissue fold8, for example, to the opposed serosal layers. By way of non-limiting example, theelectrodes1960, operating in either a bipolar or monopolar mode, can deliver RF energy to thetissue fold8 such that the interior serosal layers of thetissue fold8 are bonded together.
• It is envisioned that reducing the volume of the gastric cavity and/or the preceding devices and procedures for reducing a gastric cavity can be supplemented by the addition of a satiety agent or a derivative thereof or analogs thereof within the digestive system. Such active agents include naturally occurring or synthetic hormones, peptides, neurotransmitters or mimetics thereof, that are capable of directly stimulating the region responsive to the satiety agent (e-g., the duodenum). Specific active agents which are useful include but are not limited to peptide hormones, agonists to peptide hormone receptors, antagonists to peptide hormone receptors, CCK (GenBank Accession No. NP-000720), Bombesin, Gastrin releasing peptide (GRP), glucagon, Enterostatin, Ghrelin, GLP-1 (glucagon-like peptide) (Bojanowska E., 2005, Med. Sci. Monit. 11:RA271-8; BYETTATM (exenatide)), PYY (le Roux CW., et al., 2005, Endocrinology. 2005 Sep. 15; GenBank Accession No. NP-004 15 I), Oxyntomodulin 15 (OXY, OXM; GenBank Accession No. P01275; Stanley S., et al., 2004, Am. J. Physiol. Gastrointest. Liver Physiol. 286(5): G693),Melanocortin 4 receptor Agonists, Apo IV (naturally occurring apoprotein Qin X, Tso P 2005, Curr Drug Targets. 6(2): 145-5 1), GI18 177 1X (GSK), anti Ghrelin agents (Kobelt P., Gut. 2005 Jun. 30; SPIEGELMER NOX-B1 I), substances that prevent the acylation of ghreling, PP (Miskowiak J, et al., 1985, Regul. Pept. 12: 231-6) and derivatives and analogs thereof such as CCK-4 (Trp-Met-Asp-Phe), CCK-8 (Asp-Tyr(S03H)-Met-Gly-Trp-Met-Asp-Phe) analogues of CCK), CCK analogs ((Sincalide by Bracco Diagnostics or Squibb Diagnostics), GSK-GW7176, GW 5283, GW7854 and Pfizer PW170292)), CCK receptor agonists (e.g., 1,5-benzodiazepines, PD 170292, SR 146 13 1) and/or activator molecules of the CCK-A receptor (JMV 180; Archer-Lahlou E, et al., 2005, 25 J. Biol. Chem., Vol. 280: 10664-10674), and PYY analogs (e.g., PYY(1-36), PYY(3-36), PYY(9-36), PYY(14-36), PYY(22-36), and PYY(27-36)).
• The satiety agent can be introduced by implanting a pump within the body or attaching a pump to the body, and the pump can have an outlet introducing the satiety agent to a portion of the digestive system where the satiety agent is found to be most effective, such as the duodenum. Alternately, the satiety agent can be administered orally in pill form or can be injected into the body. The satiety agent can also be sprayed or poured in liquid form on the interior surface of the digestive system.
• A kit may be described containing devices and satiety agents needed to perform a method of plicating a gastric cavity and introducing a satiety agent. The kit can include, for example, an apparatus for reducing the volume of the gastric cavity, a satiety agent, and an introducer for the satiety agent.
• It is further envisioned that a procedure for forming a tissue fold within the gastric cavity can be supplemented by surgically altering another portion of the digestive system. For example, one portion of the digestive system can be transposed to another portion of the digestive system. As further example, a surgeon can reduce the volume of the gastric cavity, remove a portion of the ileum, and anastomose the portion of the ileum to reside in-line with a section of the duodenum. The surgeon can then anastomose the open sections of ileum where the transposed portion was removed to recreate a continuous digestive system. A surgeon can use, for example, an Echelon™ Endoscopic Linear Cutter, available from Ethicon Endo-Surgery, in Cincinnati, Ohio, to perform the anastomoses. Without being limited by theory, it is believed that transposing a section of the ileum to the duodenum may reduce a patient's cholesterol and/or increase a patient's lean muscle mass. Satiety agents can also be introduced as described above.
• It is further envisioned that the techniques described herein for endoscopic plication formation can be combined with devices and/or methods to implant a duodenal barrier in a gastrointestinal tract containing a volume reduction procedure as described in more detail in U.S. Patent Publication No. 2009/0276055 entitled “Method for Gastric Volume Reduction Surgery,” filed on May 1, 2008, which is hereby incorporated herein in its entirety.
• Additional kits can be provided containing devices for performing gastric volume reduction and ileal transposition. For example, a can may contain one or more of the following: a device for gastric volume reduction; a device for transposing the ileum; a satiety agent; and an introducer for the satiety agent.
• Further, any and all of the various embodiments of the surgical devices embodiments disclosed herein can be interchangeable with one another as needed. For example, any of the end effectors described above can be associated with a fastener configured to deliver energy to a tissue fold to secure adjacent layers of tissue that form the tissue fold.
• Further, as the surgical device is delivered to the desired surgical site, a risk can exist that the device can tear or puncture nearby tissue. Accordingly, in any and all of the embodiments described herein, a safety shield can optionally be included to reduce the risk of tearing or puncture by the surgical device. In general the shield can be of a material that is relatively smooth to allow ease of passage of instruments, but resistant to tearing and puncture. For example, the shield can be formed of silicone, urethane, thermoplastic elastomers, rubber, polyolefins, polyesters, nylons, fluoropolymers, and any other suitable materials known in the art. The shield can be detachable from a surgical access device so it can be used as needed in a particular procedure. The shield can also be integral with the any of the surgical access device embodiments or any of the components described herein. The components themselves can also act as shields.
• In any and all of the surgical devices disclosed herein, an engagement and/or release mechanism can be included to allow one component to be separated from another component or to allow one portion of a component to be separated from another portion of a component. For example, a jaw can be separable from the end effector. The engagement or release mechanism can be a latch, switch, c-clamp, tabs, push button, or any other mechanism known in the art that can be configured to release one portion of a device from another.
• There are various features that can optionally be included with any and all of the surgical device embodiments disclosed herein. For example, a component of the device, such as the elongate shaft, end effector, tissue manipulator, or fastener, can have one or more lights formed thereon or around a circumference thereof to enable better visualization when inserted within a patient. As will be appreciated, any wavelength of light can be used for various applications, whether visible or invisible. Any number of working channels, suspension members or tethers, seal housings, and seal elements can be included on and/or through the retractor to enable the use of various surgical techniques and devices as needed in a particular procedure. For example, openings and ports can allow for the introduction of pressurized gases, vacuum systems, energy sources such as radiofrequency and ultrasound, irrigation, imaging, etc. As will be appreciated by those skilled in the art, any of these techniques and devices can be removably attachable to the surgical access device and can be exchanged and manipulated as needed.
• The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
• Typically, the invention described herein will be processed before surgery. First, new or used surgical instruments and access devices are obtained and cleaned, if necessary. The surgical equipment can then be sterilized. Any number of sterilization techniques known to those skilled in the art can be used to sterilize the equipment including beta or gamma radiation, ethylene oxide, steam, and a liquid bath (e.g., cold soak). In one sterilization technique, the equipment is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and equipment are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the equipment and in the container. The sterilized equipment can then be stored in the sterile container. The sealed container keeps the equipment sterile until it is opened in the medical facility.
• The foregoing description of preferred embodiments of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the teachings in the art. The embodiments were chosen and described in order to best illustrate the principles of the invention and its practical application to thereby enable one of ordinary skill in the art to best utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Claims (29)

1. A method for forming an endoluminal fold of tissue within a body cavity, comprising:

inserting an instrument having a flexible shaft and an end effector into a body cavity through a natural opening in a body, the end effector having first and second jaws effective to define a tissue receiving cavity having a first length in a delivery configuration;

manipulating the end effector to cause the tissue receiving cavity to have a second length greater than the first length;

manipulating tissue to create a tissue fold that is positioned within the tissue receiving cavity; and

fastening the tissue fold to secure adjacent layers of tissue that form the tissue fold, the depth of the tissue fold being substantially the same as the second length and greater than the first length.

2. The method ofclaim 1, wherein manipulating the end effector comprises manipulating the jaws.

3. The method ofclaim 2, wherein manipulating the jaws comprises distally extending extension members coupled thereto.

4. The method ofclaim 1, wherein the end effector further comprises a sheath disposed around the jaws in the delivery configuration, and wherein manipulating the end effector comprises retracting the sheath such that the jaws extend distally therefrom.

5. The method ofclaim 1, wherein manipulating the tissue comprises removably engaging tissue with a tissue manipulator associated with the end effector.

6. The method ofclaim 5, further comprising retracting the tissue manipulator to pull the tissue within the tissue receiving cavity.

7. The method ofclaim 6, wherein the jaws are manipulated after the tissue manipulator is retracted.

8. The method ofclaim 6, wherein the jaws are manipulated before the tissue manipulator is retracted.

9. The method ofclaim 1, wherein the end effector has a maximum length in the delivery configuration, and wherein the tissue fold has a depth greater than the maximum length of the end effector in the delivery configuration.

10. The method ofclaim 1, wherein fastening the tissue fold comprises securing adjacent layers of tissue that form the tissue fold.

11. The method ofclaim 10, wherein securing adjacent layers of tissue comprises inserting a tissue fastener therethrough.

12. The method ofclaim 10, wherein securing adjacent layers of tissue comprises applying energy to the tissue fold to bond the adjacent layers of tissue that form the tissue fold.

13. An endoscopic instrument, comprising:

an elongate, flexible shaft having proximal and distal ends;

an end effector disposed at the distal end of the shaft, the end effector including a tissue receiving cavity, the tissue receiving cavity having a first length in a delivery configuration and a second length in a treatment configuration, the second length being greater than the first length;

a tissue manipulator associated with the end effector, the tissue manipulator configured to engage tissue to enable the tissue to be positioned within the tissue receiving cavity in the treatment configuration to create a tissue fold; and

a fastener configured to secure adjacent layers of tissue that form the tissue fold disposed within the tissue receiving cavity, the tissue fold having a depth greater than the first, delivery length of the tissue receiving cavity.

14. The endoscopic instrument ofclaim 13, wherein the end effector further includes first and second jaws that define the tissue receiving cavity.

15. The endoscopic instrument ofclaim 13, wherein the tissue manipulator is axially extendable and retractable.

16. The endoscopic instrument ofclaim 13, wherein the tissue manipulator comprises a distal tip configured to removably couple to tissue.

17. The endoscopic instrument ofclaim 16, wherein the distal tip comprises at least one of a corkscrew, a vacuum port, and a clamp.

18. The endoscopic instrument ofclaim 13, further comprising a stabilization element configured to constrain lateral movement of the tissue manipulator.

19. The endoscopic instrument ofclaim 18, wherein the stabilization element comprises a sheath disposed around the tissue manipulator.

20. The endoscopic instrument ofclaim 18, wherein the stabilization element comprises a housing coupled to the tissue manipulator, the housing being slidably coupled to the end effector.

21. The endoscopic instrument ofclaim 13, wherein the first length of the tissue receiving cavity is substantially zero.

22. The endoscopic instrument ofclaim 14, further comprising a moveable sheath, wherein the jaws are disposed within the sheath in the delivery configuration.

23. The endoscopic instrument ofclaim 22, wherein the sheath is configured to be proximally retracted in the treatment configuration.

24. An endoscopic instrument, comprising:

an elongate, flexible shaft having proximal and distal ends;

an end effector having first and second arms disposed at the distal end of the shaft, the end effector moveable from a delivery configuration to a treatment configuration, and having a first maximum rigid length in the delivery configuration and wherein the first and second arms define a tissue receiving cavity in the treatment configuration;

a tissue manipulator associated with the end effector, the tissue manipulator configured to engage tissue to enable the tissue to be positioned within the tissue receiving cavity in the treatment configuration to create a tissue fold; and

a fastener configured to secure adjacent layers of tissue that form the tissue fold disposed within the tissue receiving cavity, the tissue fold having a depth greater than the maximum rigid length of the end effector in the delivery configuration.

25. The endoscopic instrument ofclaim 24, wherein at least one of the arms comprises a segmented arm formed of a plurality of connected link segments.

26. The endoscopic instrument ofclaim 25, further comprising an actuator coupled to the segmented arm, the actuator being configured to move the segmented arm between a flexible configuration and a rigid configuration.

27. The endoscopic instrument ofclaim 25, wherein the link segments are flexibly coupled relative to one another in the delivery configuration, forming a flexible segmented arm.

28. The endoscopic instrument ofclaim 25, wherein the link segments are rigidly coupled relative to one another in the treatment configuration, forming a rigid segmented arm.

29. The endoscopic instrument ofclaim 24, wherein the end effector has a maximum rigid length in the treatment configuration greater than the maximum rigid length in the delivery configuration.

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